Global Assistant Director - MCOQ US Assistant Director

This position will ensure excellence in Marketing Company GMP & GDP Quality activities to maintain the local License to Operate (LTO), driving compliance, quality performance, and continuous improvement across the US market and aligned cluster.

Key Responsibilities

• Governance and Leadership

  • Serve as back-up to the Cluster Lead as the GMP/GDP contact for the region. Maintain an effective governance structure that provides transparent oversight of quality activities and risk management.

  • Act as a core member of the Marketing Company Quality Regional Leadership Team, contributing to strategy, prioritization, and resource planning.

  • Lead, manage, and develop team members in a multi-layered organization; set objectives and build capabilities to deliver against global processes and local needs.
     

• Strategy, Policy, and Quality System Execution

  • Collaborate with the US Cluster to define and deploy the GMP & GDP strategy across markets and the commercial SET area, partnering with Commercial SET leaders, Regional Commercial Heads, and Global Patient Safety.

  • Shape and execute the Marketing Company GMP/GDP Quality System and framework, including change control, quality events, CAPA oversight, deviation/incident management, and documentation practices.

  • Define, implement, and monitor GMP/GDP policies and standards in market; drive global standardization, simplification, and continuous improvement of Marketing Company Quality processes.
     

• Management Review, Performance, and Reporting

  • Support the Marketing Company Quality Management Review (QMR) process, including preparation, execution, and escalation to Operations, Commercial, and R&D senior leadership and SET members.

  • Contribute to compliance and performance reporting to AstraZeneca Operations Leadership for Marketing Company Quality metrics and insights.

  • Support budget planning and management for the Marketing Company Quality organization.
     

• Regulatory Compliance and Inspection Readiness

  • Maintain current knowledge of country-specific regulatory requirements for manufacturing and distribution; ensure audit/inspection readiness and compliance to sustain AZ’s LTO.

  • Lead/oversee resolution of Issue Management, FARs, BPDRs, recalls, and regulatory interactions as appropriate, ensuring timely and compliant outcomes.
     

• US Product Quality Complaints (PQC) Leadership

  • Act as Regional Process Champion for the PQC process.

  • Oversee end-to-end US PQC intake, triage, and communication to supply sites, ensuring consistent, clear, and timely reporting aligned with AZ policies.

  • Integrate across stakeholders (MCOQ Regional Process Network, US Operations, US Patient Safety, global supply sites) to ensure awareness of new programs and drive customer feedback into supply and functional teams.

  • Partner with the AZ Information Center (AZIC) to maintain an accurate, comprehensive knowledge base aligned to US PQC policies.

  • Collaborate with the Vendor Management Team to monitor IQVIA performance (e.g., weekly quality checks), identify opportunities, and drive improvements.

  • Support projects, pilots, and initiatives aligned to supply site, US Operations, and US Commercial goals.

  • Support and participate in internal audits and external regulatory inspections of the US PQC process.

  • Provide oversight for Drug Quality MedWatch reports from FDA in accordance with local requirements.

  • Stay current with evolving US regulatory requirements and best practices related to PQCs.
     

• People and Capability

  • Provide training, support, and coaching on GMP/GDP requirements and practices to Marketing Company personnel.

  • Contribute to integration activities for divestments, acquisitions, and licensing agreements by providing Marketing Company GMP/GDP quality input for the region.

​Essential Qualifications

• Qualified to degree level (Bachelor's) preferably in a science /
  technical field such as Pharmacy, Biology, Chemistry or Engineering

• Minimum of 7 years in Operations or Quality Assurance within either the pharmaceutical industry, Biopharma or medical device industries .

• Demonstrated strong level knowledge of GMP/GDP quality management processes. Key focus area on Complaint Management skills.

• Ability to support delivery near and longer term of Marketing Company GMP/GDP strategy across market in AZ Commercial network and partners.